Hologic Receives 510k Clearance to Use Hip Structure AnalysisTM in DXA Systems
by Barbara Kram, Editor | September 19, 2006
BEDFORD, Mass. -- The U.S. Food and Drug Administration (FDA) has cleared the incorporation of proprietary Hip Structure Analysis software for use in Hologic dual-energy x-ray (DXA) bone densitometers.
HSATM is a leading hip structure analysis method for DXA scans in research and pharmaceutical studies. HSA uses specialized software to examine the structural geometry of two-dimensional DXA scan images. This technology is designed to assist physicians in determining if a patient's bones have been weakened so as to require treatment and, if the patient is being treated, whether the patient's bones are getting stronger. This new feature represents a significant advance in densitometry as compared to conventional bone density scanners which only look at average density.
Thomas J. Beck, Sc.D., associate professor of radiology in The Johns Hopkins University School of Medicine, compares HSA and bone density to the situation faced by engineers in measuring the safety of a bridge. Engineers know that while the density of a bridge's supports significantly influences its safety, that factor alone is not enough to determine if the bridge is safe enough to cross.
Beck points out that the stresses of a bridge (or a bone) under a particular load are largely determined by the amount of material and its distribution within the structure. "Hip Structure Analysis algorithms allow us to calculate both the bone mineral density as well as the structural geometry that underlies bone strength from DXA measurements," Beck says. "The use of HSA should result in more definitive measures of bone health."
Beck and his colleagues in JHU's School of Medicine are widely recognized for their work in the development of biomechanical parameters of hip structure derived from densitometric information. Hologic's software builds upon technology developed by APL and recently acquired by Hologic.
"DXA systems have advanced well beyond bone mineral density measurements," says Brad Herrington, Hologic Vice President of Skeletal Health Imaging. "Clinicians have long sought the next generation of osteoporosis assessment tools to better predict femur fracture risk. Vertebral Fracture Assessment and Hip Structure Analysis have brought us into that generation. We thank Dr. Beck and his colleagues for having faith in Hologic and allowing us the exclusive use of their work for our bone densitometer systems."
While HSA represents an important breakthrough, in the beginning it will primarily be used in bone research. In studies, HSA may help researchers understand how the femur weakens with age and how pharmaceutical treatments work to reduce fracture risk at the hip.
HSA is a trademark of The Johns Hopkins University Applied Physics Laboratory.
About Hologic
Hologic Inc. is a leading developer, manufacturer and supplier of premium diagnostic and medical imaging systems dedicated to serving the healthcare needs of women, and a leading developer of innovative imaging technology for digital radiography and breast imaging. Hologic's core business units are focused on mammography and breast biopsy, osteoporosis assessment, and mini C-arm and extremity MRI imaging for orthopedic applications. For more information visit www.hologic.com.
About The Johns Hopkins University Applied Physics Laboratory
The Applied Physics Laboratory is a not-for-profit laboratory and division of The Johns Hopkins University. APL conducts research and development primarily for national security and for nondefense projects of global significance. For information, visit www.jhuapl.edu.
HSATM is a leading hip structure analysis method for DXA scans in research and pharmaceutical studies. HSA uses specialized software to examine the structural geometry of two-dimensional DXA scan images. This technology is designed to assist physicians in determining if a patient's bones have been weakened so as to require treatment and, if the patient is being treated, whether the patient's bones are getting stronger. This new feature represents a significant advance in densitometry as compared to conventional bone density scanners which only look at average density.
Thomas J. Beck, Sc.D., associate professor of radiology in The Johns Hopkins University School of Medicine, compares HSA and bone density to the situation faced by engineers in measuring the safety of a bridge. Engineers know that while the density of a bridge's supports significantly influences its safety, that factor alone is not enough to determine if the bridge is safe enough to cross.
Beck points out that the stresses of a bridge (or a bone) under a particular load are largely determined by the amount of material and its distribution within the structure. "Hip Structure Analysis algorithms allow us to calculate both the bone mineral density as well as the structural geometry that underlies bone strength from DXA measurements," Beck says. "The use of HSA should result in more definitive measures of bone health."
Beck and his colleagues in JHU's School of Medicine are widely recognized for their work in the development of biomechanical parameters of hip structure derived from densitometric information. Hologic's software builds upon technology developed by APL and recently acquired by Hologic.
"DXA systems have advanced well beyond bone mineral density measurements," says Brad Herrington, Hologic Vice President of Skeletal Health Imaging. "Clinicians have long sought the next generation of osteoporosis assessment tools to better predict femur fracture risk. Vertebral Fracture Assessment and Hip Structure Analysis have brought us into that generation. We thank Dr. Beck and his colleagues for having faith in Hologic and allowing us the exclusive use of their work for our bone densitometer systems."
While HSA represents an important breakthrough, in the beginning it will primarily be used in bone research. In studies, HSA may help researchers understand how the femur weakens with age and how pharmaceutical treatments work to reduce fracture risk at the hip.
HSA is a trademark of The Johns Hopkins University Applied Physics Laboratory.
About Hologic
Hologic Inc. is a leading developer, manufacturer and supplier of premium diagnostic and medical imaging systems dedicated to serving the healthcare needs of women, and a leading developer of innovative imaging technology for digital radiography and breast imaging. Hologic's core business units are focused on mammography and breast biopsy, osteoporosis assessment, and mini C-arm and extremity MRI imaging for orthopedic applications. For more information visit www.hologic.com.
About The Johns Hopkins University Applied Physics Laboratory
The Applied Physics Laboratory is a not-for-profit laboratory and division of The Johns Hopkins University. APL conducts research and development primarily for national security and for nondefense projects of global significance. For information, visit www.jhuapl.edu.
